25 August 2022 | News
Launches ATH434 phase 2 clinical trial for the treatment of patients with multiple system atrophy in Europe
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Australia-based Alterity Therapeutics has announced that the company’s Phase 2 clinical trial of ATH434 for the treatment of patients with Multiple System Atrophy (MSA) is now open for enrolment in the United Kingdom.
“Our Phase 2 clinical trial continues to progress as planned with the launch of the study in the UK for patients with MSA,” said David Stamler, M.D., Chief Executive Officer, Alterity. “In a short period of time we have now commenced enrolment in our second region, and we look forward to broadening our reach over the next several months. Because MSA is a rare disease, we are committed to providing access to the trial to eligible patients globally.”
The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled investigation of ATH434 in patients with early-stage MSA. The study will explore the effect of ATH434 treatment on neuroimaging and protein biomarkers, such as excess brain iron and aggregating α-synuclein, which are important contributors to MSA pathology. Clinical endpoints will permit comprehensive assessment of ATH434 efficacy along with characterization of safety and pharmacokinetics.
The use of wearable sensors will allow evaluation of motor parameters that are important in patients with MSA. The study is expected to enroll approximately 60 adult patients to receive one of two dose levels of ATH434 or placebo. Patients will receive treatment for 12 months which will provide an opportunity to detect changes in efficacy endpoints to optimize design of a definitive Phase 3 study.